MAUDE Adverse Event Report: TOSOH AIA ST AIA-PACK BETA HUMAN CHORIONIC GONADOTROPIN ASSAY

Model Number N/A

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed in response to complaints of a false positive result for beta human chorionic gonadotropin (bhcg) and an error 2231 b/f probe 1 overflow sensor failure on the tosoh aia-900 analyzer.The device was being used for diagnosis during the complaint event.At the customer site a tosoh field service engineer (fse) was unable to reproduce the error 2231.The nurses at the site questioned the result and asked the tech to re-run the sample and it was repeated five times with good reproducibility.In conclusion, this investigation confirmed no failure of the tosoh aia-900 analyzer or the reagent.A 13-month complaint and service history review for lot number b217153 from the date of (b)(6) 2020 through aware date (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.A 13-month complaint and service history review for serial number (b)(4) from the date of (b)(6) 2020 through aware date (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.The aia-900 operator's manual under section 12 - flags and error messages states the following: [2231] bf overflow sensor 1 failure: cause: the overflow sensor 1 s132 is detecting liquid constantly.Action: please contact the tosoh local representatives.Check s132.Specimen collection and handling: serum or heparinized plasma is required for the assay.Edta and citrated plasma should not be used.No special patient preparation is necessary.When using serum, a venous blood sample is collected aseptically without additives.Store at 18 - 25 °c until a clot has formed (usually 15 - 45 minutes), then centrifuge to obtain the serum specimen for assay.To use heparinized plasma, a venous blood sample is collected aseptically with the designated additive.Centrifuge and separate plasma from the packed cells as soon as possible.Samples may be stored at 2 - 8 °c for up to 24 hours prior to analysis.If the analysis cannot be done within 24 hours, the sample should be stored frozen at -20 °c or below for up to 60 days.Repeated freeze-thaw cycles should be avoided.Turbid serum samples or samples containing particulate matter should be centrifuged prior to testing.Prior to assay, slowly bring frozen samples to room temperature (18 - 25 c) and mix gently.The sample required for analysis is 50 l.

Event Description

Imprecision on sample results was noticed on beta human chorionic gonadotropin (bhcg).Customer also reported an error 2231 bf overflow sensor 1 failure.New information was received from the field service engineer (fse) after being dispatched to site.A false positive result was actually reported.This is a reportable event based on potential discrepant patient results for beta human chorionic gonadotropin (bhcg).

• Brand Name: ST AIA-PACK BETA HUMAN CHORIONIC GONADOTROPIN ASSAY
• Type of Device: ST AIA-PACK BETA HUMAN CHORIONIC GONADOTROPIN ASSAY
• Manufacturer (Section D): TOSOH AIA; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH AIA; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12409049
• MDR Text Key: 271947429
• Report Number: 3004529019-2021-00021
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 025261
• Device Lot Number: B217153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1